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FDA rejects elvitegravir, cobicistat as stand-alone treatment
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The FDA notified Gilead Sciences this week that it cannot approve its new drug applications for elvitegravir and cobicistat for use as part of HIV treatment regimens, according to a press release from Gilead.
The letter from the FDA cited deficiencies in documentation and validation of certain quality testing procedures and methods that were observed during recent inspections as reasons for the rejection. Gilead said it is working with the FDA to address the issues raised in the complete response letters.
Elvitegravir and cobicistat also are components of the manufacturer’s once-daily single tablet HIV-1 regimen Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), which was approved by the FDA in August for treatment-naive adults. This regulatory action does not affect the marketing authorization or continued use of that combination product.
Gilead submitted its new drug applications for elvitegravir and cobicistat in June. Marketing applications also are pending in Europe.